When developing a new drug for the market, companies have several categories they can go through depending on the type of drug and what part of the process they are in. Each category has a special requirement that must be met in order to get approval from the FDA. Their goal is to ensure the safety and efficacy of any new application before it makes it onto the market.
Animal Pharmacology and Toxicology Studies
Clinical Protocols and Investigator Information
Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug.
an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling.
Issuance of a biologics license is a determination that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity and potency of the product.
Get assistance with meeting the requirements of the FDA to ensure a quick approval process and avoid any delays or rejections.